The Principal Data Manager at Wave Life Sciences will play a key role in clinical trial design and implementation by ensuring that trial data is collected, curated and documented efficiently and appropriately. The Principal Data Manager will be a member of clinical trial management teams and will demonstrate diligence in all data-related activities.
The Principal Data Manager will be responsible for managing and executing the design, testing, implementation and documentation of the clinical database build activities; collection and review of internal and external datasets; and the adherence to relevant processes throughout the lifecycle of clinical trials. The Principal Data Manager is responsible for preserving data integrity and adhering to deadlines to achieve accurate and timely regulatory submissions and publications.
Oversight of Data Management external vendors (CROs) for outsourced study activities such as CRF development, database set-up activities, data validation process, medical coding, SAE reconciliation, training of study site personnel in CRF completion, lab data transfer specifications, and data clarification processes.
Oversight of data review activities (cleaning activities including internal cross functional listing review, external data reconciliation and data review), ensure completion of all activities for any deliverables, and manage all activities leading to the study database lock.
Where applicable, ensure consistency and data standards are followed across projects in data collection and processes.
Provide creative and effective ways to resolve complex data related or system related issues using professional concepts and considering company objectives.
Ensure Data Management activities are conducted according to applicable regulations and per the protocol.
Oversee or execute Case Report Form and Completion Guideline development and approval.
Oversee or develop Data Management Plan
Oversee the development of Data Transfer Agreements between the Data Management CRO and the External data vendors.
Serve as lead Data Manager on assigned clinical trials and attend clinical trial study team meetings.
Serve as the technical consultant ensuring appropriate development, maintenance, and use of data capture technologies for assigned projects.
Contribute as a reviewer from Data Management group for study protocols and amendments to the protocols.
Responsible for archival of data and study specific data management documentation.
Independently monitor own activities and project status for successful project deliverables according to timelines.
Demonstrated Project Management experience
9-12 years of experience in Data Management
Proficient in Electronic Data Capture (EDC) systems such as Medidata Rave
Experience with CDASH, SDTM, and medical coding dictionaries MedDRA, WHO Drug
Good understanding of ICH, GCP and other applicable regulatory guidelines
Effective verbal and written communication skills
Capable of working on multiple projects simultaneously
Requires a bachelor's degree in a scientific discipline or equivalent. Master's degree is preferred.
Wave Life Sciences